FDA Device Establishments · JSON-LD · Markdown
FEI 3008514395 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active
| FEI Number | 3008514395 |
|---|---|
| Owner / Operator | Philips Medical Systems International BV (#1217116) |
| Address | 600 West Ridge Road, Suite 200, Linwood, PA, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 4 |
| Product codes (top 20) | JQP, NBW, CGA, JJX |
| Regulation § (21 CFR) | 862.2100, 862.1345, 862.1660 |
| Proprietary names | Philips Ambulatory Virtual Care Blood Glucose Monitoring System; Telcare BGM; Telcare Blood Glucose Monitoring System; BioTel Care BGM; Telcare Cloud; BioTel Care Blood Glucose Monitoring System; Telcare |
Source: openFDA. Public-domain (CC0).